A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
GlaxoSmithKline · NCT07701993
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 1740
- US sites recruiting
- 13
- Study start
- July 22, 2026
- Record last updated
- September 30, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.
Being studied: Efimosfermin alfa; Placebo
Conditions: Metabolic Dysfunction-associated Steatohepatitis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Participants aged between 18 and 75 years at enrollment.
- Participants with compensated cirrhosis due to MASH, confirmed by non-invasive assessments.
- Participants with history or presence of at least two components of metabolic syndrome.
Exclusion Criteria
- Participants with other chronic liver diseases.
- Participants with evidence or history of decompensated liver disease or hepatocellular carcinoma.
- Participants with history of Type 1 diabetes mellitus or major Type 2 diabetes complications.
- Participants with history or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before screening.
- Participants with a recent history or planned surgical procedures or medications intended to produce significant weight loss.
- Participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >=5 times upper limit normal (ULN).
- Participants with current or history of excessive alcohol intake.
Recruiting US locations
GSK Investigational Site
Little Rock, AR 72211
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Folsom, CA 95630
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Miami, FL 33135-4661
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Miami, FL 33155
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Ocala, FL 34471
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
St Louis, MO 63141
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Arlington, TX 76012
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Austin, TX 78745-5675
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Bellaire, TX 77401
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Dallas, TX 75243-1921
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Humble, TX 77346
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
San Antonio, TX 78209
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
San Antonio, TX 78215
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
Study contacts (from the official record)
- US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
- EU GSK Clinical Trials Call Center · +44 (0) 20 89904466 · GSKClinicalSupportHD@gsk.com
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